LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE LFD-2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00859623006315), received between Oct 24, 2018 and Mar 27, 2020 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRODUCT PACKAGING HAD AN OPENING/TEAR UPON INSPECTION. CANNOT CONFIRM IF IT WAS RECEIVED AS IS OR IF IT WAS DUE TO MISHANDLING AT THE CUSTOMER SITE. THE PRODUCT WAS NOT USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9892372 ↗
• MalfunctionOct 12, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  CUSTOMER REPORTED THAT UPON REMOVING PRODUCT FROM THE BOX THE INNER POUCH PACKAGE WAS ALREADY OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9183159 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEW DAYS AFTER LIPIFLOW TREATMENT THE PATIENT DEVELOPED A CHALAZION IN THE RIGHT EYE. THE EYE WAS RED AND SORE. SYMPTOMS STARTED TO DEVELOP IN THE LEFT EYE AS WELL AFTERWARD. THERE WERE NO ISSUES DURING THE TREATMENT AND SHE HAD NONE VISIBLE ON THE DAY OF TREATMENT. NO TREATMENT AT THE TIME WAS GIVEN. DURING FOLLOW UP IT WAS REPORTED THAT PATIENT STARTED USING AN ANTIBIOTIC DROP. IT WAS ALSO REPORTED THAT THE PATIENT HAD STYES AND NOT CHALAZIONS. THIS REPORT IS FOR THE LEFT EYE. A REPORT FOR THE RIGHT EYE IS BEING SUBMITTED FOR SEPARATELY.

  Patient problems: No Code Available

  MAUDE report 9146259 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEW DAYS AFTER LIPIFLOW TREATMENT THE PATIENT DEVELOPED A CHALAZION IN THE RIGHT EYE. THE EYE WAS RED AND SORE. SYMPTOMS STARTED TO DEVELOP IN THE LEFT EYE AS WELL AFTERWARD. THERE WERE NO ISSUES DURING THE TREATMENT AND SHE HAD NONE VISIBLE ON THE DAY OF TREATMENT. NO TREATMENT AT THE TIME WAS GIVEN. DURING FOLLOW UP IT WAS REPORTED THAT PATIENT STARTED USING AN ANTIBIOTIC DROP. IT WAS ALSO REPORTED THAT THE PATIENT HAD STYES AND NOT CHALAZIONS. NOTE: THIS REPORT IS FOR THE RIGHT EYE. A REPORT FOR THE LEFT EYE IS BEING SUBMITTED FOR SEPARATELY.

  Patient problems: No Code Available

  MAUDE report 9146243 ↗
• MalfunctionJun 7, 2019Unsealed Device Packaging; Unsealed Device Packaging

  A SURGERY CENTER REPORTED OBSERVED A LIPIFLOW ACTIVATOR NOT SEALED UPON OPENING THE OUTER BOX. A DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT 1 OF 10 LIPIFLOW ACTIVATORS THAT WERE INDIVIDUALLY PACKAGED WAS NOT SEALED AND WAS AT THE BOTTOM OF THE BOX. THE REMAINING 9 ACTIVATORS WERE SEALED. THE UNSEALED PACKAGE WAS DISCOVERED PRIOR TO USE AND DURING HANDLING. NO PATIENT CONTACT OR PATIENT INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8678608 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD TREATMENT WITH LIPIFLOW SYSTEM FOR DRY EYE ON (B)(6) 2018 AND PRESENTED ON (B)(6) 2018 WITH HORDEOLUM IN THE LEFT EYE. PATIENT WAS TREATED WITH ANTIBIOTICS. IT WAS REPORTED THAT ACTIVATOR DEVICE WAS DISCARDED.

  Patient problems: No Code Available

  MAUDE report 7999502 ↗